[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07700368":3,"trial-entities:NCT07700368":90,"trial-summary:NCT07700368":93},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":44,"secondary_outcomes":49,"sex":50,"minimum_age":51,"maximum_age":16,"healthy_volunteers":52,"eligibility_criteria":53,"std_ages":65,"locations":68,"central_contacts":84,"overall_officials":87,"references":88,"see_also_links":89},"NCT07700368","IRB25-1212","Effect of Monosodium Glutamate on Microbiome-Derived Imidazole Propionate Production in Healthy Volunteers","NOT_YET_RECRUITING","2027-12-31","2026-07","2026-07-14","2026-07-15","University of Chicago","OTHER",false,"The goal of this clinical trial is to learn whether dietary monosodium glutamate (MSG), a common food flavor enhancer, increases the blood level of a gut-microbiome-derived compound called imidazole propionate (ImP) in healthy adult volunteers. ImP is a compound made by gut bacteria from the amino acid histidine, and higher blood levels have been linked to problems with blood-sugar control. The main questions this trial aims to answer are:\n\nDoes taking MSG together with L-histidine increase blood ImP levels compared with taking a salt (sodium chloride) placebo together with L-histidine? How do blood ImP levels change over time in response to MSG and L-histidine taken together?\n\nResearchers will compare a 7-day period of L-histidine plus MSG against a 7-day period of L-histidine plus sodium chloride (a salt placebo with matching sodium content) to see whether MSG changes blood ImP levels. Each participant completes both periods in random order and serves as their own comparison.\n\nParticipants will:\n\nTake L-histidine capsules twice daily (morning and evening with meals) during two separate 7-day periods.\n\nDissolve either MSG powder or salt powder in water and drink it twice daily during each period, with the two periods separated by a 7-day break (washout).\n\nGive a fasting blood sample at the start of the study and on day 7 of each period.\n\nOptionally provide a stool sample at the end of each period. Complete a daily treatment diary and a follow-up phone call after the final sample.",null,[18],"Healthy Adult",[20],"Monosodium glutamate","INTERVENTIONAL","BASIC_SCIENCE",[24],"NA",{"count":26,"type":27},18,"ESTIMATED",[29,36,40],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DIETARY_SUPPLEMENT","L-histidine","USP-grade L-histidine, 4 g\u002Fday, taken as capsules divided into 2 g in the morning and 2 g in the evening with meals, during each 7-day treatment period. Administered in both treatment periods for all participants.",[34,35],"Sequence 1: L-histidine + MSG, then L-histidine + NaCl","Sequence 2: L-histidine + NaCl, then L-histidine + MSG",{"type":30,"name":37,"description":38,"armGroupLabels":39},"Monosodium glutamate (MSG)","Food-grade monosodium glutamate, 3 g\u002Fday, provided as identical-appearing single-dose powder sachets divided into 1.5 g in the morning and 1.5 g in the evening, each dissolved in approximately 240 mL",[34,35],{"type":30,"name":41,"description":42,"armGroupLabels":43},"Sodium chloride (NaCl)","USP-grade sodium chloride, 940 mg\u002Fday, provided as identical-appearing single-dose powder sachets divided into 470 mg in the morning and 470 mg in the evening, each dissolved in approximately 240 mL of water and taken with meals during the placebo treatment period. The sodium content is matched to that of the 3 g\u002Fday MSG dose to isolate the effect of glutamate.",[34,35],[45],{"measure":46,"description":47,"timeFrame":48},"Difference in blood imidazole propionate concentration between the monosodium glutamate and sodium chloride treatment periods","Blood imidazole propionate concentration measured by liquid chromatography-mass spectrometry (LC-MS) from the blood sample collected on day 7 of each 7-day treatment period. The outcome is the within-participant difference between the day-7 concentration following the L-histidine + MSG period and the day-7 concentration following the L-histidine + NaCl period.","Day 7 of each treatment period",[],"ALL","18 Years",true,{"inclusion":54,"exclusion":57,"raw_text":64},[55,56],"Age 18 years or older","No antibiotic use in the previous 3 months",[58,59,60,61,62,63],"Diagnosis of diabetes or prediabetes (any type)","Inflammatory bowel disease or other gastrointestinal disorder","Known allergy or intolerance to monosodium glutamate (MSG)","Pregnancy or breastfeeding","Current participation in another clinical trial","High habitual dietary intake of MSG or histidine","Inclusion Criteria:\n\n* Age 18 years or older\n* No antibiotic use in the previous 3 months\n\nExclusion Criteria:\n\n* Diagnosis of diabetes or prediabetes (any type)\n* Inflammatory bowel disease or other gastrointestinal disorder\n* Known allergy or intolerance to monosodium glutamate (MSG)\n* Pregnancy or breastfeeding\n* Current participation in another clinical trial\n* High habitual dietary intake of MSG or histidine",[66,67],"ADULT","OLDER_ADULT",[69],{"facility":70,"city":71,"state":72,"zip":73,"country":74,"contacts":75,"geoPoint":81},"Duchossois Family Institute, Knapp Center for Biomedical Discovery (KCBD), Room 4214","Chicago","Illinois","60637","United States",[76],{"name":77,"role":78,"phone":79,"email":80},"Sam Light","CONTACT","773-702-3435","samlight@uchicago.edu",{"lat":82,"lon":83},41.85003,-87.65005,[85],{"name":86,"role":78,"phone":79,"email":80},"Sam Light, PhD",[],[],[],{"nct_id":4,"conditions":91,"biomarkers":92},[18],[],{"nct_id":4,"found":52,"summary":94,"prompt_version":104},{"design":95,"status":96,"heading":97,"summary":98,"follow_up":99,"word_count":100,"commitments":101,"compensation":102,"drugs_mentioned":103},"This is an interventional study involving 18 healthy adult volunteers. Participants will receive L-histidine along with either monosodium glutamate or sodium chloride (salt) placebo.","completed","Monosodium Glutamate and Imidazole Propionate Production in Healthy Adults","This study is looking at whether monosodium glutamate (MSG), a common food flavor enhancer, affects the levels of a substance called imidazole propionate (ImP) in your blood. ImP is made by gut bacteria and has been linked to blood sugar control issues. Researchers want to see if taking MSG along with L-histidine (a dietary supplement) increases blood ImP levels compared to taking a salt placebo with L-histidine. They will also track how ImP levels change over time. You can join if you are a healthy adult, aged 18 or older, and have not used antibiotics recently. You cannot participate if you have diabetes, inflammatory bowel disease, an MSG allergy, or are pregnant or breastfeeding. The study plans to enroll 18 healthy volunteers.","Blood imidazole propionate concentration will be measured at Day 7 of each treatment period.",122,"Participants will take L-histidine, 4 g\u002Fday, and either monosodium glutamate, 3 g\u002Fday, or sodium chloride, 940 mg\u002Fday, for 7 days during each treatment period.","Not stated in the trial record.",[31,37],"v2"]